Watch: Journalist Alex Berenson on FDA Failure to Report Death of Young Child in Moderna Trials
The U.S. Food and Drug Administration (FDA) likely knew about a child’s death from cardio-respiratory arrest during a clinical trial for Moderna’s COVID-19 booster but did not publicly disclose it.
The U.S. Food and Drug Administration (FDA) likely knew about a child’s death from cardio-respiratory arrest during a clinical trial for Moderna’s COVID-19 booster, but did not publicly disclose it — and neither did the drugmaker, according to documents uncovered by investigative reporter Alex Berenson.
Berenson, a former New York Times reporter who now publishes the Unreported Truths Substack, discussed details of the story in this week’s edition of “The Defender In-Depth.”
Berenson said the death occurred in late 2022 or early 2023, during the Omicron wave of the COVID-19 pandemic. It was disclosed only to European regulators, who have stricter reporting requirements than some other countries, including the U.S.
Around that time, some European countries stopped recommending COVID-19 shots for kids based on evidence of low efficacy and children’s ability to recover from the virus on their own. However, the U.S. continues to recommend them.
With a new administration about to be sworn in, the FDA may now face an investigation into the child’s death, Berenson said.
Berenson, who previously was censored by social media platforms for posts about injuries related to the COVID-19 vaccines, also addressed Meta CEO Mark Zuckerberg’s recent revelations about White House pressure to censor the content. He also discussed his censorship lawsuit against the Biden administration.
FDA, Moderna ‘sat on’ information about child death during clinical trial
According to Berenson, during 2021 and 2022, the outcomes of clinical trials for the COVID-19 vaccines were “not particularly impressive,” particularly in children. Yet, there was “a lot of pressure on the FDA to move ahead quickly with the trials.”
Despite the shortcomings of the vaccines and their ineffectiveness against new COVID-19 strains, Berenson said it was “pretty clear” by early 2022 that public health agencies would approve the COVID-19 vaccines for children.
“That made zero sense … healthy children and even not particularly healthy children are at very low risk from COVID,” Berenson said. “We don’t know what the long-term impact of the mRNA vaccines is. It’s one thing if you’re 80 years old. It’s another thing if you’re going to be living with the downstream effects of this for a lifetime.”
Berenson said companies and public health agencies “continued to push” for the vaccines, resulting in efforts, in late 2022, to promote Omicron-specific boosters.
According to Berenson, Moderna conducted its KidCOVE clinical trial during this period, with the participation of approximately 12,000 children. It was during this trial that a child, likely between 2 and 5 years of age and from either the U.S. or Canada, died.
Berenson said that the FDA likely learned of the child’s death later, but never publicly shared the information. Moderna only disclosed the death to European regulators — along with the claim that the child’s death was unrelated to the vaccine.
According to Berenson, pertinent information about the child remains undisclosed. “We don’t even know the gender of the child, the race of the child, the age of the child, where this happened, how many days or weeks after the shot it occurred. We just know the child died and [Moderna] sat on it and FDA sat on it,” Berenson said.
Berenson said the child likely was previously in good health because the trial “was designed to enroll healthy children.” He added that while few children today are receiving COVID-19 shots “because parents have finally figured out that mRNA is not something they want to be exposing their kids to,” this was not the case in 2022.
“Two years ago, this was still an active issue and millions of kids got those shots in the fall and winter of 2022. I think they would’ve liked to have known this,” Berenson said.
‘FDA didn’t really want to answer my questions’
Berenson said that when he approached the FDA with questions about the child’s death, the agency was evasive.
“FDA didn’t really want to answer my questions about this initially … and I followed up with them and I hammered them,” Berenson said. “They continued to stonewall me, but they did essentially give me a second statement [where] they don’t deny that there was a death in the trial or that they know about it.”
According to Berenson, the FDA told him it is not allowed to disclose deaths during the pre-approval process for a drug.
“That’s a very interesting way to frame this, considering that the FDA and everybody else have been saying these drugs are safe and effective,” Berenson said. He added that Moderna and Dr. C. Buddy Creech, a Vanderbilt University professor who was a lead investigator on the KidCOVE trial, have not responded to requests for comment.
Berenson said the FDA may soon have to provide public answers about the clinical trial. Berenson said Sen. Ron Johnson (R-Wis.) has disclosed that he will subpoena the FDA for information on the KidCOVE trial and the child’s death.
‘Nobody wants the shots’
In 2021, Berenson was banned by Twitter — now known as X — for his posts on COVID-19 vaccine injuries, under pressure from the Biden administration. He told “The Defender In-Depth” that he welcomed recent developments supporting free speech, including Zuckerberg’s recent statements about Meta’s policies to this effect.
“There’s no question that Facebook, Meta … were pressured by the White House,” Berenson said.
Berenson also referred to his lawsuit, Berenson v. Biden, currently before a federal court in New York. Oral arguments in the case are pending. Berenson said he amended his complaint after previous revelations by Zuckerberg — to Sen. Jim Jordan (R-Ohio) — that the White House pressured him to censor content on Meta-owned platforms.
Berenson said Zuckerberg’s admissions are “directly relevant” to his lawsuit.
According to Berenson, Zuckerberg’s recent admissions are part of a broader shift in public opinion on topics ranging from free speech to vaccines.
“There’s 100% a shift in public perception,” Berenson said. “Moderna stock is down almost 95% from its highs. They had to cut their sales estimates … Nobody wants the shots.”
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Thank You for posting this!
When actually reading the entire published report on the children trials, there seem to be more shady stuff going on than this one child. Just one example, the number of 'dropping out of the study' is astonishing...No exaplanation for that. The really big one seemed to me to be actually the procedure of the 'proof' of efficiency, which would equally question all the studies performed on adults...